AWMSG recommends SPRYCEL® for use in NHS Wales. Welsh guidance goes further than the SMC

January 21, 2008:

The All Wales Medicines Strategy Group (AWMSG) has today announced that SPRYCEL® (dasatinib) should be recommended for restricted use within NHS Wales for the treatment of adults with chronic or accelerated phase chronic myeloid leukaemia (CML), where there is resistance or intolerance to prior therapy including imatinib mesylate.

Although use in blast phase patients was not
recommended by the AWMSG, most CML patients are diagnosed in the chronic phase and so this recommendation will encompass the majority of eligible patients.

Commenting on the news, Dr Saad Al-Ismail, Lead Consultant Haematologist, Singleton Hospital, Swansea, said, “This is excellent news for the people in Wales living with CML, and for those new patients diagnosed every year. The AWMSG’s decision means that dasatinib, an effective treatment for CML, is now readily available for those chronic and accelerated phase patients who become resistant or intolerant to imatinib.”

The Scottish Medicines Consortium (SMC) and London Cancer New Drugs Group (LCNDG) issued
their positive advice on SPRYCEL in April 5th and May 6th 2007, respectively.

The LCNDG supported the use of SPRYCEL in imatinib mesylate resistant or intolerant CML patients of all phases while the SMC only recommended SPRYCEL for those patients in the chronic phase.

This new Welsh guidance goes further than the SMC, making the drug available to those imatinib intolerant or resistant patients in the chronic or accelerated phases of CML.

All Wales Medicines Strategy Group Advice- CML:

Dasatinib (Sprycel®) is recommended for restricted use within NHS Wales for the treatment of adults with chronic phase chronic myeloid leukaemia (CML) and accelerated phase CML where there is
resistance or intolerance to prior therapy including imatinib mesilate.
The use of dasatinib for blast phase is not recommended.

Resistance to imatinib is defined in accordance with the European LeukaemiaNet criteria and on completion of mutation analysis.

Intolerance is defined as a patient experiencing prior grade 3/4 toxicity, in accordance with the National Cancer Institute Common Toxicity Criteria, to imatinib despite receiving the lowest clinically effective dose.

Dasatinib (Sprycel®) should only be initiated by specialists experienced in the treatment of chronic myeloid leukaemia.

Dasatinib (Sprycel®) is not presently recommended for shared care.

Ph+ ALL and LB-CML:
Dasatinib (Sprycel®) is not recommended for use within NHS Wales for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast chronic myeloid leukaemia (LB-CML) with resistance or intolerance to prior therapy.

About SPRYCEL®
SPRYCEL is indicated for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate.

It is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.